TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
A&E MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX, INC
	SUBSTANTIALLY EQUIVALENT	1
CIRCUMFIX SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K231333 STRETTO™ Cable System
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEOS SURGERY SL
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
	SUBSTANTIALLY EQUIVALENT	2
RIVERPOINT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	166	166
Adverse Event Without Identified Device or Use Problem	156	156
Break	155	155
Device-Device Incompatibility	33	33
Fracture	30	30
Migration	24	24
Device Slipped	19	19
Insufficient Information	16	16
Material Deformation	12	12
Crack	6	6
Material Frayed	5	5
Migration or Expulsion of Device	5	5
No Apparent Adverse Event	5	5
Failure to Cut	5	5
Material Fragmentation	5	5
Appropriate Term/Code Not Available	4	4
Entrapment of Device	3	3
Material Separation	3	3
Device Appears to Trigger Rejection	2	2
Detachment of Device or Device Component	2	2
Product Quality Problem	2	2
Failure to Osseointegrate	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Patient Device Interaction Problem	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Patient-Device Incompatibility	2	2
Degraded	1	1
Unraveled Material	1	1
Device Difficult to Setup or Prepare	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Fail-Safe Mechanism	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Device Contamination with Chemical or Other Material	1	1
Unintended Movement	1	1
Material Disintegration	1	1
Physical Resistance/Sticking	1	1
Nonstandard Device	1	1
Malposition of Device	1	1
Connection Problem	1	1
Naturally Worn	1	1
Mechanical Jam	1	1
Loss of Osseointegration	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	270	270
Unspecified Infection	66	66
Pain	44	44
Non-union Bone Fracture	43	43
Insufficient Information	40	40
No Code Available	37	37
Failure of Implant	31	31
No Consequences Or Impact To Patient	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
No Known Impact Or Consequence To Patient	13	13
Post Operative Wound Infection	12	12
No Patient Involvement	11	11
Bone Fracture(s)	11	11
Hypersensitivity/Allergic reaction	10	10
Metal Related Pathology	9	9
Fall	9	9
Hemorrhage/Bleeding	7	7
Unspecified Tissue Injury	7	7
Adhesion(s)	6	6
Hip Fracture	6	6
Death	6	6
Inflammation	5	5
Foreign Body In Patient	5	5
Discomfort	5	5
Malunion of Bone	5	5
Swelling/ Edema	4	4
Injury	4	4
Loss of Range of Motion	4	4
Inadequate Osseointegration	3	3
Hematoma	3	3
Bacterial Infection	3	3
Joint Dislocation	3	3
Impaired Healing	3	3
Fluid Discharge	3	3
Edema	2	2
Joint Contracture	2	2
Ossification	2	2
Cellulitis	2	2
Nerve Damage	2	2
Wound Dehiscence	2	2
Scar Tissue	2	2
Fibrosis	1	1
Erosion	1	1
Bruise/Contusion	1	1
Tissue Damage	1	1
Joint Laxity	1	1
Muscle/Tendon Damage	1	1
Pneumonia	1	1
Abscess	1	1
Balance Problems	1	1